高醫黃志仁/北榮蕭正英 執行 喬本植物新藥adlay bran, JBM-TC4 (phase II Prevents Acute Radiodermatitis in Breast Cancer Patients )

喬本生醫4/20每股48元登興櫃 旗下癌症新藥進入臨床2期 鉅亨網／鉅亨網記者張旭宏 台北-2015年04月14日 上午09:00 專攻牛樟植育的喬本生醫(4193-TW)，敲定4月20日以每股48元登錄興櫃交易，成為興櫃生技股一員，公司預計最快明年上半年完成上櫃掛牌。公司今年前二月稅後虧損573萬元，每股淨損0.16元。旗下癌症JBM-TC4植物新藥已進入美國臨床2期。喬本生醫2010年獨立分割餘喬志亞生技南科分公司，2012年正式進駐屏東農業生物技術園區，全力開發超臨界二氧化碳萃取技術，開創植物新藥、本土中草藥、保健食品及醫美抗老化產品，同時開發牛樟芝子實體，啟動積極啟動生技新藥計劃。喬本生醫表示，公司運用核心技術加值天然中草藥成功開發的JBM-TC4植物新藥，2013年3月取得美國FDA-PhaseⅡ人體臨床核准，5月也順利通過TFDA核准二期人體臨床試驗，預期JBM-TC4植物新藥開發成功，將可提供全球癌症患者更多有效治療用藥選擇，而複合成份植物藥可以搭配單一成份的小分子藥，是未來癌症整合式治療的趨勢。喬本生醫指出，透過超臨界二氧化碳流體萃取技術(CO2-SFE)技術，加上擬態移動床層析技術(Simulated Moving Bed,SMB)平台生產，超臨界CO2流體萃取-功能性、專利性原創材料製造及銷售，另外原創材料生產自有品牌JBM保健產品系列、牛樟芝子實體護肝及癌症輔療保健產品，最後植物新藥開發商品化製程，目前運用於JBM-TC4植物新藥及牛樟芝子實體新藥開發。喬本生醫進一步指出GMP藥廠建置喬本雲端環控系統，運用RFID晶片紀錄牛樟芝生產履歷，透過牛樟椴木銷售及代客培育植菌牛樟椴木子實體、ODM牛樟芝子實體滴丸保健品，提供國內外客戶ODM及銷售通路合作。

This study will be conducted in 2 sites in Taiwan. Upon confirmation of meeting all eligibility criteria, will be randomized in a 1:1:1 ratio to 2000 mg or 3000 mg JBM-TC4 oral treatment group or to placebo control group. The treatment will start one week prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks of JBM-TC4. The patients will take 3 treatment capsules twice a day, after breakfast and dinner. Screening visit will occur up to 14 days prior to randomization (Day 0), and informed consent form will be signed and patient eligibility criteria will be verified. Medical history information, chemistry/hematology evaluation, serum pregnancy will be conducted and documented. On Day 0, baseline assessment will be done and study drug will be dispensed. The patients will be instructed to start their study medication after breakfast on Day 1 and record the administration time in the study diary. Post-operative radiotherapy will begin for all patients after taking the treatment for 7 days. On Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 and 92, data including radiation dermatitis severity, redness and pain scale will be collected when patients return to the clinic for evaluation. On Days 29, 57, 85 and 92, quality of life questionnaire will be completed by patients and blood will be drawn for chemistry/hematology evaluation. The final study visit will occur one week after the last dose of study medication, which will be around Day 92. ECG will be evaluated on Day 8 and 92. A total of 120 women with breast cancer will be recruited into this study. Safety will be assessed through recording of adverse events, assessment of vital signs, and chemistry/hematology laboratory testing. During each clinic visit, investigator will take down the vital signs of the patients and ask if the patients has experienced any adverse events. All information will be recorded on the case report form. The primary efficacy endpoint in this study is to assess the effectiveness of JBM-TC4 for the prevention and treatment of acute radiation-induced dermatitis. The  effectiveness will be determined by the recording of the radiation dermatitis severity scale for patients during each weekly study visit. Secondary efficacy endpoint include 1) Presence of moist desquamation and 2) redness at the radiation treated site at any visit. 3)The worst pain related to dermatitis between baseline and follow-up visit at the radiotherapy site. 4) Quality of life and 5) safety evaluation assessment. At the final visit, each investigator will be ask to rate their patients' responses to treatment.